AccessGUDID - DEVICE: Portrait Toxigenic C. difficile Assay (B178GBCDIFF100)

GUDID

Device Identifier (DI) Information

Brand Name: Portrait Toxigenic C. difficile Assay
Version or Model: GBCDIFF-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GBCDIFF-10
Company Name: GREAT BASIN SCIENTIFIC, INC.

Primary DI Number: B178GBCDIFF100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827115259 *Terms of Use

Device Description: C. diff Assay Cartridge and Sample Prep Device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61735	Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid which encodes for toxin B production from Clostridium difficile bacteria in a clinical specimen, using a nucleic acid technique (NAT).	Obsolete	false
50836	Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZN	C.Difficile Toxin Gene Amplification Assay
OMN	C. Difficile Nucleic Acid Amplification Test Assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9e7e8d7-7858-4547-96d9-9009bcb4e1ff
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016